APEX study

• Research type

  Research Study

• Full title

  Arthroplasty Pain Experience Study (APEX): A randomised controlled trial to determine if local wound infiltration reduces chronic pain after lower limb arthroplasty.

• IRAS ID

  20798

• Contact name

  Ashley Blom

• Sponsor organisation

  North Bristol NHS Trust

• Eudract number

  2009-013817-93

• ISRCTN Number

  n/a

• Research summary

  Joint replacement is one of the most common elective surgical procedures performed in the NHS. However, previous research indicates that between 10-30% of patients experience chronic joint pain after hip and knee replacement. Therefore, more research is required to explore methods of minimizing chronic pain after joint replacement. The aim of this study is to determine whether an injection of local anaesthetic into the hip or knee during joint replacement surgery, in addition to standard anaesthetic, reduces long-term pain. To do this, 300 patients listed for knee replacement and 300 patients listed for hip replacement will be recruited into a randomised controlled trial. Eligible patients will be those with a diagnosis of osteoarthritis who are placed on the list for a primary total hip or total knee replacement at the Avon Orthopaedic Centre. Participants will be randomised to receive either the standard anaesthetic regimen or the standard anaesthetic regimen plus an injection of local anaesthetic directly into the wound during surgery. Participants in the study will be asked to complete questionnaires to assess their joint pain and function, psychological status, and use of healthcare resources. Participants will complete questionnaires before their operation, and after their operation while they are an in-patient with the help of a research nurse. Following discharge from hospital, participants will be asked to complete postal questionnaires at 3-months and 6-months post-surgery. At 12-months post-surgery participants will be asked to complete a final questionnaire and undergo a joint assessment with a research nurse. Also, a small number of participants and health care professionals will be interviewed about their participation in the study, in order to find out how participation in the trial affects them.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/94

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion